APPLICATION
NDA020233
TYPE
NDA
ORIGINAL APPROVAL
1994-02-14
LATEST ACTION
2001-12-11
ROUTE
NASAL
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
RHINOCORTDiscontinued
BUDESONIDE 0.032MG/INH · AEROSOL, METERED · NASAL
Approval history
2001-12-11Manufacturing (CMC) · Supplement 13 · standardAP
2001-10-02Manufacturing (CMC) · Supplement 11 · standardAP
2001-06-19Manufacturing (CMC) · Supplement 12 · standardAP
2001-02-21Manufacturing (CMC) · Supplement 10 · standardAP
2000-06-02Labeling · Supplement 9 · standardAP
1999-10-21Manufacturing (CMC) · Supplement 8 · standardAP
1998-09-30Labeling · Supplement 6 · standardAP
1998-06-08Manufacturing (CMC) · Supplement 5 · standardAP
1996-11-15Labeling · Supplement 4 · standardAP
1996-11-15Manufacturing (CMC) · Supplement 2 · standardAP
1994-02-14Type 1 - New Molecular Entity · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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